Validation Times articles from January 2006

Validation Times archives from January 2006

Draft guidance for GMPs in Phase I drug development provides first update since 1991.(Clinical supplies)
January 1, 2006... FDA Jan. 12 published its draft guidance titled "INDs--Approaches to Complying with GMPs During Phase I," the first time FDA has provided new guidance in this area since 1991. According to the agency, the document provides "FDA's current...

CBER guidance on post-approval changes, seen in late '06, to give reprieve to hot-water WFI systems.(CMC/biologics)
January 1, 2006... SAN FRANCISCO -- FDA's Center for Biologics expects to issue revised guidance this year for reporting post-approval changes to biological products, with an increased focus on a risk-based approach that will make reporting requirements less...

PCR-based test speeds detection of mycoplasma contaminants: Genentech.(Impurities)
January 1, 2006... SAN FRANCISCO -- Preliminary data from a multi-company study indicates that a PCR [polymerase chain reaction] -based test can reproducibly speed detection of mycoplasma contaminants in biotech products, compared with the standard FDA-approved...

Final guidance for GMP inspection dispute resolution does not cover PAI issues.(Inspections)
January 1, 2006... FDA released Jan. 11 its final guidance titled "Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP," which does not apply to pre-approval or pre-licensing inspections, and the agency...

Approaches exist to deal with regional specifications.(Specifications)
January 1, 2006... SAN FRANCISCO -- Despite attempts at global harmonization, specifications still vary from country to country, which is one reason that manufacturing for different markets continues to present big challenges. Yet there are approaches that...

Banner fails to follow stability program in 6-item 483.(Human drugs)
January 1, 2006... Banner Pharmacaps, High Point, NC, was slapped with a six-item 483 because it did not follow its written stability-testing program and failed to adequately document its out-of-specification investigations (OOS). The inspection, conducted...

Bristol-Myers Squibb ducks 483, despite failure to maintain validation records.
January 1, 2006... Bristol-Myers Squibb's manufacturing facility in Anagni, Italy, was cited for failure to maintain validation records following a recent audit. However, no 483 was issued because the agency concluded this was an "isolated incident," according to...

Los Angeles-based Chemica receives 4-item 483 for stability test chamber flaws.
January 1, 2006... No temperature mapping studies for stability test chambers resulted in a four-item 483 for Los Angeles-based Chemica. The report, which was prepared by investigator Virgilio Pacio from the Irvine, CA, District Office, stated that Chemica...

Egyptian device firm tripped up by insufficient QS audits and process validation errors.(Medical devices)
January 1, 2006... Haidylena for Advanced Medical Products, October City, Egypt, received a five-item 483 because it was lacking an adequate and effective quality system, and processes whose results could not be fully verified were not adequately validated. The...

Carrington warned for microoganism in mouthwash.(Human drugs)
January 1, 2006... During an Aug. 24-30, 2005, FDA audit, samples were collected for analytical testing at Carrington Laboratories, Irving, TX, and for a determination regarding compliance. Analysis found the presence of the microorganism Burkholderia cepacia in...

Process controls and calibration checks lacking for Nephron Pharmaceuticals.(Human drugs)
January 1, 2006... After the March 21-28, 2005, inspection of Nephron Pharmaceuticals, Orlando, FL, FDA found serious deviations of the post-marketing adverse drug experience (PADE) reporting requirements, as well as violations of the current GMP requirements for...

CAPAs and quality data cited for Guidant.(Medical devices)
January 1, 2006... During an Aug. 22-Sept. 1, 2005, inspection of the Guidant Corp, Minneapolis, MN, FDA concluded that the firm's St. Paul location was not in conformance with the current GMP requirements of the QS regulation. Violations noted in the Dec....

LifeScan tripped up by failure to meet specs.(Medical devices)
January 1, 2006... After an April 6-June 30, 2005, inspection, FDA determined that LifeScan, Milpitas, CA, the manufacturer of OneTouch Ultra and the OneTouch UltraSmart Blood Glucose Meters, was not in conformance with the current GMP requirements of the Quality...

Normed fails to validate 'with high degree of assurance'.(Medical devices)
January 1, 2006... An inspection at Normed Medizin-Technik, Tuttlingen, Germany from July 11-14, 2005, revealed that the firm's devices--including various distraction and titanium bone plates, as well as surgical devices--were not in conformance with the current...

CAPAs, process analysis and quality records flawed for device firm.(Medical devices)
January 1, 2006... A June 28-July 1, 2005, investigation of Restorative Products, Tampa, FL, elicited an extensive list of violations. GMP violations noted in the Dec. 2, 2005, warning letter included that the manufacturer failed to establish and maintain...